Necessity of Esophageal Dissection During Laparoscopic Fundoplication
Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children
1 other identifier
interventional
177
1 country
2
Brief Summary
This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2006
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 6, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedSeptember 22, 2009
March 1, 2009
3.5 years
February 6, 2006
September 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hiatal hernia
1 year
Secondary Outcomes (2)
control of symptoms
1 year
retching
1 year
Study Arms (2)
1
ACTIVE COMPARATORArms:Lap. Fundo. with Mobilization of the Esophageal Junction
2
EXPERIMENTALInterventions
Complete mobilization of the esophageal junction
phrenoesophageal membrane left intact
Eligibility Criteria
You may qualify if:
- Under 18 years of age
- Gastroesophageal Reflux Disease
You may not qualify if:
- Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy
- Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
- Prior operation for congenital diaphragmatic hernia
- Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)
- Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Related Publications (1)
van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136.
PMID: 35171266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shawn D St. Peter, MD
Children's Mercy Hospital Kansas City
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 6, 2006
First Posted
February 7, 2006
Study Start
February 1, 2006
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
September 22, 2009
Record last verified: 2009-03